Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

This study has been completed.
Sponsor:
Collaborator:
B. Braun Medical SA
Information provided by (Responsible Party):
Hua Zheng, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01289548
First received: February 2, 2011
Last updated: July 8, 2013
Last verified: September 2012

February 2, 2011
July 8, 2013
May 2010
November 2011   (final data collection date for primary outcome measure)
  • Plasma Creatine Concentration of the Recipients [ Time Frame: within the first 3days after the operation ] [ Designated as safety issue: No ]
    Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping
  • Urinary Output of the Recipients Postoperatively [ Time Frame: within the first 3days after the operation ] [ Designated as safety issue: No ]
    Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation
  • Plasma Concentration of NGAL in the Recipients [ Time Frame: within the first 24hours after the operation ] [ Designated as safety issue: No ]
    Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping
renal function of recipients after living-related kidney transplantation [ Time Frame: 72 postoperative hours ] [ Designated as safety issue: No ]
Serum creatinine concentration and Urine output before surgery and at 1, 4, 24, 48, and 72 h after unclamping
Complete list of historical versions of study NCT01289548 on ClinicalTrials.gov Archive Site
  • Acute Rejection of Transplanted Kidney [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
    biopsy-confirmed, clinically symptomatic
  • Delayed Graft Function [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
    Delayed Graft Function according to the clinical symptoms
  • Length of Postoperative Hospital Stay [ Time Frame: before discharge ] [ Designated as safety issue: No ]
    time from the day of operation to the day of discharge for the recipients
  • Total Costs During the Hospitalization [ Time Frame: from the admission to the discharge of the patients ] [ Designated as safety issue: No ]
    Total costs from the admission to the discharge of the recipients
  • Urine Concentration of NAG Preoperatively in Recipients [ Time Frame: before operation ] [ Designated as safety issue: No ]
    Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation
  • Urine Concentration of NAG Postoperatively in Recipients [ Time Frame: within the first 24hours after the artery unclamping ] [ Designated as safety issue: No ]
    Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients
  • Urine Concentration of RBP Preoperatively in the Recipients [ Time Frame: before the operation ] [ Designated as safety issue: No ]
    Urine concentration of retinol binding protein (RBP) before the operation in the recipients
  • Urine Concentration of RBP Postoperatively in the Recipients [ Time Frame: within the first 24hours after the artery unclamping ] [ Designated as safety issue: No ]
    Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients
  • Plasma Concentration of SOD in the Recipients [ Time Frame: within 24hours after the operation ] [ Designated as safety issue: No ]
    Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
  • Plasma Concentration of MDA in the Recipients [ Time Frame: within the first 24hours after the operation ] [ Designated as safety issue: No ]
    Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
  • hemodynamic parameters [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
    blood pressure (BP), heart rate (HR), central venous pressure (CVP) and SpO2
  • 0peration time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • warm ischemic time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • cold ischemic time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • Acute rejection of transplanted kidney [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
    biopsy-confirmed, clinically symptomatic
  • Delayed Graft Function [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
    clinically symptomatic
  • Length of postoperative hospital stay [ Time Frame: before discharge ] [ Designated as safety issue: No ]
  • Ischemia reperfusion injury of recipients after living-related kidney transplantation [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: No ]
    urine N-acetyl-β-D-glucosaminidase and Retinol binding protein before surgery and at 1, 4 and 24h after unclamping; Serum Superoxide dismutase and Malondialdehyde before surgery and at 1, 4 and 24h after unclamping
Not Provided
Not Provided
 
Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation

Ischemia reperfusion injury (IRI) induced renal failure after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effects of IRI after organ transplantation various strategies aimed at the different pathophysiological processes of IRI have been investigated. Remote ischemic preconditioning (RIPC) is one such strategy where brief IRI of one organ protects other organs from sustained IRI. Many studies have shown that RIPC protects heart, muscle flaps, stomach, liver, lungs, and kidneys from IRI. RIPC of the limb with a tourniquet is a safe and convenient method of preconditioning organs against IRI. However, the efficacy of RIPC in patients undergoing living donor kidney transplantation need to be established and mechanism of early and late RIPC, such as whether the donor should undergo remote preconditioning or the recipient, need to be investigated.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Kidney Diseases
  • Kidney Failure, Chronic
  • Kidney Failure
  • Renal Insufficiency
  • Renal Insufficiency, Chronic
  • Urologic Diseases
Device: remote ischaemic preconditioning
Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Other Name: RIPC
  • No Intervention: control
    patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
  • Experimental: donor
    Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
    Intervention: Device: remote ischaemic preconditioning
  • Experimental: recipient
    recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
    Intervention: Device: remote ischaemic preconditioning
Chen Y, Zheng H, Wang X, Zhou Z, Luo A, Tian Y. Remote ischemic preconditioning fails to improve early renal function of patients undergoing living-donor renal transplantation: a randomized controlled trial. Transplantation. 2013 Jan 27;95(2):e4-6. doi: 10.1097/TP.0b013e3182782f3a.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation
  • Living donors
  • Compatible ABO blood type
  • PRA < 20%

Exclusion Criteria:

  • Re-transplant patients
  • Those with peripheral vascular disease affecting the lower limbs
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01289548
TJMZK201001
No
Hua Zheng, Huazhong University of Science and Technology
Huazhong University of Science and Technology
B. Braun Medical SA
Study Chair: Yuke Tian, M.D. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Huazhong University of Science and Technology
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP